K241620 is an FDA 510(k) clearance for the ChestView US. This device is classified as a Analyzer, Medical Image (Class II - Special Controls, product code MYN).
Submitted by Gleamer Sas (Paris, FR). The FDA issued a Cleared decision on February 27, 2025, 267 days after receiving the submission on June 5, 2024.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2070. For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers.
| 510(k) Number | K241620 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2024 |
| Decision Date | February 27, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MYN - Analyzer, Medical Image |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2070 |
| Definition | For Information On The Myn Device, Please See: Https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers |